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Recruiting Observational

Cardiovascular Health in Adult Patients With Cancer Exposed to Cardiotoxic Therapies

NCT06664528 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-02-28
Last updated
2025-03-04

Condition(s) studied

Cardiac ToxicityCancer

Investigational drug(s) / intervention(s)

ECHOCARDIOGRAPHYELECTROCARDIOGRAPHY (ECG)LABORATORY TESTS

ECHOCARDIOGRAPHY: A complete echocardiographic exam will be performed during each cardio-oncologic evaluation.

ELECTROCARDIOGRAPHY (ECG): An ECG tracing will be obtained during each cardio-oncologic evaluation.

LABORATORY TESTS: The cardiac biomarkers high-sensitivity troponin I and N-terminal pro-B-type natriuretic peptide (NT-proBNP) will be dosed according to the current recommendations of Cardio-Oncology Guidelines.

Study summary

The goal of this observational study is to evaluate the cardiovascular health and prognosis of adult patients with cancer, treated with cardiotoxic therapies.

The main purposes of the study are the following:

* Identify the demographic factors related to the onset of cardiotoxicity produced by anticancer drugs.
* Identify any subgroups more likely to develop distant major adverse cardiovascular events (MACE).
* Evaluate the usefulness of clinical, biohumoral and echocardiographic parameters for early diagnosis of cardiotoxicity.

Participants will be monitored during the anticancer treatment via clinical, laboratory and instrumental evaluation according to the recommendation of the current guidelines on Cardio-Oncology (European Society of Cardiology, 2022). Initial follow-up will be 2 years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients over the age of 18 at the time of evaluation * Patients treated with potentially cardiotoxic anticancer drugs * Patients for which complete clinical, electrocardiographic and echocardiographic data are available at first evaluation and at least at one follow-up visit. Exclusion Criteria: * Patients under the age of 18 at the time of evaluation * Patients whose documentation of the first visit is not available * Patients for whom it is not possible to obtain follow-up information through a medical visit or by telephone * Patient with poor acoustic window for echocardiographic examination. * Refusal of informed consent to participate in the study.

Primary outcome measure(s)

  • Incidence of cardiotoxicity — 24 months
    Incidence of cancer therapy-related cardiovascular toxicity according to the definitions of the European Society of Cardiology Cardio-Oncology Guidelines, published in 2022.
  • Identification of major cardiovascular adverse events (MACE) — 24 months
    Identification of cardiovascular death, non-cardiovascular death and hospitalization for cardiac causes (congestive heart failure, major arrhythmias) both during the antineoplastic treatments and in the long-survivors population.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS;UOSD diagnostica cardiologica non invasiva Rome Lazio Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06664528 on ClinicalTrials.gov ↗ ← All trials in Italy